First line oral vinorelbine in elderly patients with advanced non-small-cell lung cancer

purpouse: the activity of vinorelbine (vrl) as single agent in treatment-na？ve inoperable non small cell cancer (nsclc) patients (pts) has been assessed in several published studies. oral and intravenous formulation have a linearity of vrl pharmacokinetics with both routes of administration. this is a study with oral vrl in first line advanced nsclc in elderly pts. patients and methods: a total of 12 chemonaive elderly pts > 70 years were recruited from october 2005 through to june 2006. principal inclusion criteria included histologically confirmed advanced nsclc, performance status < 2, measurable disease, appropriate bone marrow and organ function. the dosage schedule was 60 mg/m2 once a week for three weeks (first cycle), followed if not toxicity by 80 mg/m2 once a week, until disease progression or development of unacceptable toxicity. results: the mean age was 74 years (range: 71 to 79), all males, and all pts stage iv. histology subtypes: adenocarcinoma in 5 pts, large cell carcinoma in 1 pts and squamous cell carcinoma in 6 pts. ps (ecog) distribution was: 3 pts with ps 1, and 9 pts with ps 2. the median weekly vrl doses was 13 (range 3-23). out of 11 pts receiving the second cycle, 7 patients went a dose escalation to 80 mg/m2. the other 4 pts remained at the 60 mg/m2 dose level. there were no complete responses (cr). two (13%) of 12 patients achieved partial response (pr). there were 6 (50%) stable disease (sd) and 4 (34%) progressive disease (pd). respect survival, the median follow-up was 4 months (range 1-9 months). until date, the median survival time (mst) and median progression-free survival had not been reached; and survival and progression-free survival was 66% in both. treatment with oral vrl in elderly patients was well tolerated, and there were no toxic deaths. no grade 4 toxicities were observed, and grade 3 toxicities were infrequent, exclusively neutropenia in 2 patients and asthenia in other 2 patients. rest of toxicities were grade 1 or 2.